Automating Compliance with AI in the MedTech SDLC

Injecting Compliance into Code: Automating Compliance with AI in the MedTech SDLC

Randy Horton

Published on: June 1st, 2026

Is your highest-paid talent stuck in a compliance trap? Your engineers should be writing code (or leveraging AI to write code), not manually generating design control documentation and traceability matrices.

When teams are pulled into repetitive compliance work, development slows. As system complexity increases, manual processes delay feedback, introduce risk, and make it harder to maintain both speed and quality.

This webinar explored how automation can be built directly into the development life cycle so compliance, testing, and resilience become part of how software is created. Instead of treating documentation and quality as separate activities, teams can make them automatic outputs of the development process. It also examines how AI is used in the SDLC to complement automation and drive further productivity gains.

Orthogonal and Ketryx shared how an automated, well-functioning SDLC changes how MedTech, SaMD, and connected device teams build, validate, and scale software under design controls.

Watch Webinar Recording

Larkin Lowrey, Senior Director of Software Engineering for Digital Health, Tandem Diabetes

Randy Horton, VP of Solutions and Partnerships, Orthogonal